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Linda Paulus is production editor for
journals at the Pharmaceutical Press, London
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An article in the September issue of Focus on Alternative and Complementary
Therapies gives an insight into the research on probiotics versus antibiotics.
Children are frequently prescribed antibiotics and it is noted that up
to 50 per cent of antibiotics may be prescribed unnecessarily and may
do substantial harm. Widespread overuse and misuse of antibiotics happen,
particularly in developing countries.
The World Health Organization has promoted a drastic reduction in the
rise of antibiotics and has recommended microbial interference therapy
(using non-pathogens to eliminate pathogens). Therapies that do not involve
antibiotics are researched and the potential for probiotic therapy to
combat antibiotic resistance has never been more pressing.
The use of probiotics in preventing the prescribing of antibiotics is
relevant in both developed and developing countries. At least seven randomised
controlled trials — involving 3,302 infants and children (most
attending day care facilities) in developed countries — have been
published on the ability of probiotic agents to prevent infectious diarrhoea
ad upper respiratory tract infections. With a reduction in the incidence
of acute diarrhoea as the outcome of the RCT, total antibiotic consumption
may also decline.
Another positive factor is that probiotics may also be of direct use
in preventing antibiotic resistance.
The authors raise the question of whether or not we can continue to risk
the current laissez-faire approach to antibiotic consumption and development.
Probiotics represent a therapy that can prevent antibiotic consumption
and thus resistance. They conclude: “This emerging therapy as a
potential combatant against antibiotic consumption, and resistance, deserves
full investigation.”
Saw palmetto and prostatic hyperplasia
A summary and commentary in FACT aims to determine the efficacy of
saw palmetto for the treatment of benign prostatic hyperplasia. The study
found that there was no significant difference between those treated
with saw palmetto and placebo in American Urological Association
Symptom
Index scores, maximal urinary flow rate, prostate size, residual
volume after voiding, quality of life, or serum-specific antigen levels
during
the one-year study.
The commentator notes that the findings of this study are in contrast
to a large body of evidence suggesting the beneficial effects of saw
palmetto. Saw palmetto is widely used in many European countries. In
fact, the US National Centre for Complementary and Alternative Medicine
was involved in helping to select the product. The commentator concludes
that this is a good RCT, but it is lacking in information mainly because
of the choice of preparation used whereby some of the details, such
as the name of the extract or name of the product, plant authentication
and details on the extraction process, were not reported and therefore
full evaluation is not possible.
The authors agree that the most significant limitation of the study
was the fact that they evaluated only one extract. They express concern,
particularly because this product is from a well-respected manufacturer
in the field of herbal medicine and that if the product lacked some
active
ingredient, this ingredient is not known.The authors wonder why there
is such a discrepancy and point out that if it is due to inadequate
blinding of participants in the placebo group, participant blinding
will require
future studies. Herbal extracts and the menopause
A further study discussed investigates the efficacy of a herbal combination
of Actaea racemosa (black cohosh) and Hypericum perforatum (St John’s
wort) extracts in women with menopausal complaints, associated with
psychological symptoms.
The fixed combination of A racemosa and H perforatum was associated
with a statistically significant reduction in neurovegetative and psychological
symptoms.
The commentator is complimentary about the use of A racemosa and H
perforatum and links it to other clinical studies that use the same ingredients
for menopausal women. However, with regard to this study, he thinks some
vital elements are missing, particularly on the allocation sequence.
He concludes that the results are promising but, before this combination
can be offered to symptomatic menopausal women, other trials are needed
to rule out any negative interactions with H perforatum.
The author thanks the commentator for the positive feedback and explains
how a relevant influence on pharmacokinetic parameters of critical products
was ruled out. Hypertension and oren-gedoku-to
A study was conducted to assess the clinical usefulness of oren-gedoku-to
(TJ-15) extract granules (a kampo medicine, manufactured by Tsumura,
Japan) for the management of the accessory symptoms of hypertension.
The authors conclude that TJ-15 was better than placebo with respect
to efficacy, safety and utility for the treatment of accessory symptoms
of hypertension.
The commentator points out that this study supports the traditional
use of this medicine for the treatment of of facial suffusion, a burning
sensation, headache, excitation, anxiety and irritability. The method
of research is approved as well, but it is pointed out that the improvements
in symptoms of hypertension occurred without an overall significant
drop
in blood pressure, contrasting with some animal studies and another
clinical study. On the whole, the commentator approves this research
and recommends
the situation when possible in herbal clinical studies. Cannabis and rheumatoid arthritis pain
A pilot study aimed to assess the efficacy of a cannabis-based medicine
in the treatment of pain due to rheumatoid arthritis. The outcome
was significantly better on morning pain on movement, quality of sleep
and disease activity score, but stiffness, a composite pain measure
and visual analogue pain score were not different from placebo.
The commentator, however, points out that the outcome did not adhere
to the American College of Rheumatology recommendations because only
two of the outcome measures were selected to assess the efficacy of
the cannabis-based medicine, and makes the researcher aware that
only three
of five assessments showed improvement of more than 20 per cent (the
recommended consensus score) and the DAS improvement was below 20 per
cent. He concludes that a very weak effect was demonstrated and the
clinical relevance needs to be shown in a greater number of patients
showing improvement.
He recommends that patients should be asked at the end of the treatment
which medicine they think they received.
The authors explain that their outcome measures were more oriented
towards joint pain and stiffness. In addition to that, they suggest
that a different
dosage should be used if the study is repeated. |
The
Pharmaceutical Journal